Adlyxin is an injectable diabetes medicine that helps control blood sugar levels. This medication helps your pancreas produce insulin more efficiently.

Adlyxin is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes.

Adlyxin is not for treating type 1 diabetes.

Stop using Adlyxin and call your doctor at once if you have nausea and vomiting with severe pain in your upper stomach spreading to your back.

Never share an injection pen, cartridge, or syringe with another person, even if the needle has been changed.

Before taking this medicine

You should not use Adlyxin if you are allergic to lixisenatide, or if you have diabetic ketoacidosis (call your doctor for treatment).

To make sure Adlyxin is safe for you, tell your doctor if you have:

• pancreatitis or gallstones;

• problems with digestion;

• alcoholism; or

• kidney disease.

Tell your doctor if you are pregnant or breastfeeding.

Follow your doctor's instructions about using this medicine if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications in both the mother and the baby.

Adlyxin can make birth control pills less effective. If you take a birth control pill, take it at least 1 hour before or 11 hours after you use Adlyxin.

Adlyxin is not approved for use by anyone younger than 18 years old.

Use Adlyxin exactly as prescribed by your doctor Follow all directions on your prescription label and read all medication guides or instruction sheets.

Adlyxin is injected under the skin. A healthcare provider may teach you how to properly use the medication by yourself.

Adlyxin is usually injected once per day within 60 minutes (1 hour) before your first meal of the day. Try to use the medicine at the same time each day.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all instructions.

Prepare an injection only when you are ready to give it. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.

Your healthcare provider will show you where on your body to inject Adlyxin. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

Never share an injection pen, cartridge, or syringe with another person, even if the needle has been changed. Sharing these devices can allow infections or disease to pass from one person to another.

You may have low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).

Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Be sure your family or close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

Adlyxin is only part of a complete treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor's instructions very closely.

Storing unopened (not in use) Adlyxin: Refrigerate and protect from light. Take the injection pen out of the refrigerator and allow it to reach room temperature before using.

Do not freeze, and throw away the medicine if it has been frozen.

Storing opened (in use) Adlyxin: Store at room temperature in the original package with the pen cap attached. Do not store with a needle attached.

The prefilled injection pen contains 14 pre-set doses for daily use. Throw the pen away after 14 days even if there is still medicine left inside.

Usual Adult Dose for Diabetes Type 2:

Initial dose: 10 mcg subcutaneously once a day for 14 days
Maintenance dose: Increase to 20 mcg subcutaneously once a day on day 15, and thereafter

Comments:
-This drug should be administered within 1 hour before the first meal of the day, preferably the same meal each day; if a dose is missed, administer within 1 hour prior to the next meal.
-Concurrent use with short acting insulin has not been studied and is not recommended.

Use: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

You should not use Adlyxin if you are allergic to lixisenatide, or if you have diabetic ketoacidosis (call your doctor for treatment).

To make sure Adlyxin is safe for you, tell your doctor if you have:

• pancreatitis or gallstones;

• problems with digestion;

• alcoholism; or

• kidney disease.

Tell your doctor if you are pregnant or breastfeeding.

Follow your doctor's instructions about using this medicine if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications in both the mother and the baby.

Adlyxin can make birth control pills less effective. If you take a birth control pill, take it at least 1 hour before or 11 hours after you use Adlyxin.

Adlyxin is not approved for use by anyone younger than 18 years old.

Wait until your next meal and use the medicine within 1 hour before you eat. Then go back to your regular injection schedule the next day. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction to Adlyxin: hives, itching, severe rash; rapid heartbeats; trouble swallowing; difficult breathing; feeling light-headed; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

• pancreatitis--severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;

• low blood sugar--headache, hunger, sweating, irritability, dizziness, nausea, fast heart rate, and feeling anxious or shaky; or

• kidney problems--little or no urination, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath.

Common Adlyxin side effects may include:

• nausea, vomiting, diarrhea;

• headache;

• dizziness; or

• low blood sugar.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Adlyxin can slow your digestion, and it may take longer for your body to absorb any medicines you take by mouth.

• If you also take acetaminophen (Tylenol), take it at least 1 hour before you use Adlyxin.

• If you also take any type of antibiotic, take it at least 1 hour before you use Adlyxin.

• If you also take a birth control pill, take it at least 1 hour before or 11 hours after you use this medicine.

Other drugs may interact with lixisenatide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.